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Novo Nordisk submits NDA for faster-acting insulin aspart
10 December 2015 • Author: Victoria White
Novo Nordisk has submitted a New Drug Application (NDA) to the US Food and Drug Administration for faster-acting insulin aspart.
Faster-acting insulin aspar is an investigational mealtime insulin developed by Novo Nordisk for the control of blood sugar levels in adults with type 1 and type 2 diabetes. It is insulin aspart (NovoRapid) in a new formulation in which two new excipients have been added to ensure early and fast absorption.
The filing is based on results from the ‘onset’ clinical trial programme, which involved approximately 2,100 adults with type 1 and type 2 diabetes. The trials evaluated the efficacy and safety of mealtime and after-meal faster-acting insulin aspart to reduce A1C levels and provide postprandial (after-meal) blood sugar control.
Faster-acting insulin aspart ‘a step forward’
“Today’s filing of faster-acting insulin aspart is a step forward in strengthening our mealtime insulin offerings for patients who require mealtime blood sugar control,” said Todd Hobbs, M.D., US chief medical officer, Novo Nordisk. “Faster-acting insulin aspart underscores our continued commitment to developing new treatment options for these patients. We look forward to working closely with the FDA on the submission and are focused on bringing the next generation of our mealtime insulin to market.”
Upon approval, Novo Nordisk intends to make faster-acting insulin aspart available in the pre-filled delivery device FlexTouch and 10 ml vial.
Earlier this month, Novo Nordisk announced it had submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency for the approval of faster-acting insulin aspart.
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